Global Quality Senior Director, Clinical Quality

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT’s active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location: Indianapolis, IN. Completed in Sept 2021, POINT's Indianapolis site is one of the largest state-of-the-art radiopharmaceutical manufacturing facilities in the world - almost as large as one and a half football fields.

Overview

• Provide quality and compliance oversight for all clinical development activities at POINT Biopharma and will perform a wide variety of activities ensuring Good Clinical Practice (GCP) compliance in accordance with applicable regulatory requirements.
• Have an in-depth understanding and significant experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities independently.
• Direct, manage, and collaborate on the internal and external GCP audit program to assure adherence to relevant FDA, EMA, ICH and other global regulations, guidelines, and procedures.
• Lead the global clinical quality team in establishing effective processes and providing guidance and support to clinical study teams.
• Ensure an appropriate and effective QMS for Clinical activities.
• Represent clinical quality expertise across the organization in GCLP and GCP.
• Create an appropriate plan for conducting external health authority inspections and internal audits.

• Establish an inspection readiness program for Clinical.
• Keep the organization updated with global health authority regulations and implement process improvements.
• Collaborate with cross-functional teams to optimize clinical quality processes.
• Communicate the changing regulatory requirements, understand the impact of changes on other quality systems, and drive change.
• Collaborate with Vendor Compliance to ensure GLP and GCLP external vendors, who provide materials and services on behalf of POINT, are appropriately approved prior to use.
• Ensure functional area management reviews are conducted; prepare appropriate metrics and present significant events to senior management.
• Provide strategic direction for the build-out and administration of Clinical Quality organization, in support of pipeline.

Objectives and Accountabilities

• Create and maintain a quality-focused culture and mindset across all staff within the organization.
• Develop and implement global quality standards and procedures to ensure the quality and reliability of products.
• Support regulatory inspections.
• This role works cross-functionally to develop strategies, set direction, plan, and prioritize initiatives that lead to the advancement of our project portfolio. This includes the: integration of the work priorities with other groups internal and external to the organization; Effective communication on such initiatives with senior leaders, peers, staff, and external stakeholders.
• Lead cross-functional efforts that manage third-party logistics production delivery and relationships for the project portfolio. Select third-party manufacturers working with Quality and Regulatory, negotiate effective technical agreements, and identify contract analytical laboratory sites through development to commercialization stages.
• Resource planning including budget and staffing model preparation (for departments, functions, or systems) and capacity monitoring of routine operations and enhancement projects.
• Manage (in-person or remotely) ongoing development programs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors and preparing periodic updates for Sr. Mgmt. as may be required by internal governance demands.
• Manage the development of QA staff, build-out of departmental leadership skill and identification of critical roles consistent with organizational growth and needs.
• Serve as a key member in delivering the company’s product portfolio, including participation in the planning of timelines, deliverables, and milestones in collaboration with other cros